2002
DOI: 10.1111/j.1348-0421.2002.tb02730.x
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A Limulus Amoebocyte Lysate Activating Activity (LAL Activity) That Lacks Biological Activities of Endotoxin Found in Biological Products

Abstract: Pyrogenic substances in influenza HA (IHA) vaccine have been controlled by the pyrogen test or the mouse body weight decreasing toxicity (BWD) test. We examined the possibility of replacing the animal tests with the endotoxin test. Commercial IHA vaccines were found to show considerable levels of LAL activity ranging from 0.2 to 160 EU/ml. However, a batch of the vaccine having even 100 EU/ml of LAL activity showed neither pyrogenicity in rabbits nor tumor necrosis factor alpha (TNF‐α) induction in RAW264.7 ce… Show more

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Cited by 7 publications
(1 citation statement)
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“…In contrast, polymyxin B failed to neutralize the activity detected by LAL assay with HMW-HA (Figure 1H). Non-endotoxin LAL assay activity of biological products is not uncommon, but require LPS inhibitors, such as polymyxin B, to validate LAL assay results[13] Taken together, results from this series of studies show that LAL activity and TNF induction by HMW-HA are endotoxin-independent..…”
Section: Resultsmentioning
confidence: 93%
“…In contrast, polymyxin B failed to neutralize the activity detected by LAL assay with HMW-HA (Figure 1H). Non-endotoxin LAL assay activity of biological products is not uncommon, but require LPS inhibitors, such as polymyxin B, to validate LAL assay results[13] Taken together, results from this series of studies show that LAL activity and TNF induction by HMW-HA are endotoxin-independent..…”
Section: Resultsmentioning
confidence: 93%